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| Name | Symbol | Market | Type |
|---|---|---|---|
| Teva Pharmaceutical Industries Ltd | NYSE:TEVA | NYSE | Depository Receipt |
| Price Change | % Change | Price | High Price | Low Price | Open Price | Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 14.08 | 14.16 | 13.96 | 14.15 | 7,051,252 | 01:00:00 |
From May 2019 to May 2024
By Angela Chen
Antares Pharma Inc. (ATRS) said the U.S. Food and Drug Administration denied its abbreviated new drug application for its generic migraine treatment.
The agency's complete response letter detailed labeling revisions and minor deficiencies, Antares said. A representative for the FDA wasn't immediately available for comment.
Abbreviated new drug applications are submitted for new generic drugs. If approved, the migraine treatment, called Sumatriptan Injection USP, would be Antares' first abbreviated new-drug application approval and the second one approved from its auto-injector platform.
New Jersey-based Antares focuses on self-administered drugs delivered through technologies such as its auto-injector.
If approved, Teva Pharmaceutical Industries Ltd. (TEVA) will distribute Sumatriptan Injection USP and share profits equally.
Shares of Antares, which were inactive premarket, have declined about 49% in the past 12 months through Friday's close.
Write to Angela Chen at angela.chen@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
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